Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03162107
Status:
COMPLETED
Last Update Posted:
2022-07-20
First Post:
2017-03-24
Brief Title:
Promoting Engagement in the Drug Resistant TBHIV Care Continuum in South Africa
Sponsor:
Centre for the AIDS Programme of Research in South Africa
Organization:
Centre for the AIDS Programme of Research in South Africa
Study Overview
Official Title:
Promoting Engagement in the Drug Resistant TBHIV Care Continuum in South Africa PRAXIS Study PRospective Study of Adherence in MXDR-TB Implementation Science
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRAXIS
Brief Summary:
The goals of this research are to understand adherence and retention in care for multi-and extensively drug-resistant tuberculosis MXDR-TB patients using a mixed methods approach
Detailed Description:
Tuberculosis TB remains the leading cause of morbidity and mortality worldwide among people living with HIV Globally incidence of multidrug-resistant tuberculosis MDR-TB and extensively drug resistant tuberculosis XDR-TB the most drug-resistant forms of TB has approximately doubled over the past fifteen years Nowhere has this increased incidence generated more concern than in South Africa where interactions between TB and generalized HIV epidemics are causing explosive TB incidence and case-fatality threatening to undermine the progress reached with antiretroviral therapy ART
Medication adherence a key predictor of outcomes in multi-and extensively drug-resistant tuberculosis MXDR-TB and HIV treatment is understudied in high burden TBHIV settings Patient losses during transitions in the care continuum are frequent increase mortality and limit control of the linked epidemics Demands of MXDR-TB HIV treatment are severe including extraordinary pill burden severe adverse effects lengthy treatment isolation and stigma with few parallels in modern medicine
This is a prospective observational cohort study for patients newly diagnosed with MXDR-TB initiating treatment A mixed method approach will be employed to address the complex research questions of distilling determinants of barriers and facilitators to both TB medications and ART this study will employ complementary qualitative and quantitative methodologies for assessing differential adherence to TB medications and ART
A sub-set of patients and health care workers will be approached for participation in focus group discussions
Medication adherence a key predictor of outcomes in multi-and extensively drug-resistant tuberculosis MXDR-TB and HIV treatment is understudied in high burden TBHIV settings Patient losses during transitions in the care continuum are frequent increase mortality and limit control of the linked epidemics Demands of MXDR-TB HIV treatment are severe including extraordinary pill burden severe adverse effects lengthy treatment isolation and stigma with few parallels in modern medicine
This is a prospective observational cohort study for patients newly diagnosed with MXDR-TB initiating treatment A mixed method approach will be employed to address the complex research questions of distilling determinants of barriers and facilitators to both TB medications and ART this study will employ complementary qualitative and quantitative methodologies for assessing differential adherence to TB medications and ART
A sub-set of patients and health care workers will be approached for participation in focus group discussions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None